Oncolytics Biotech® Highlights Transformative Pelareorep Survival Data in Multiple Tumors and Commitment to Registration-Enabling Studies
Oncolytics Biotech (NASDAQ: ONCY) has announced transformative survival data for its immunotherapy drug pelareorep across multiple tumor types. The company reported a significant two-year survival benefit of 21.9% vs. 9.2% in pancreatic cancer (mPDAC) studies. In HR+/HER2- metastatic breast cancer trials, pelareorep demonstrated a median overall survival benefit exceeding 10 months compared to standard chemotherapy.
Key clinical achievements include a 62% objective response rate in mPDAC when combined with chemotherapy and checkpoint inhibitors. The drug's safety profile has been validated across more than 1,100 patients, showing manageable side effects. Pelareorep holds Fast Track designations for both metastatic breast cancer and mPDAC, along with Orphan Drug Designations for pancreatic cancer from both FDA and EMA.
Oncolytics Biotech (NASDAQ: ONCY) ha annunciato dati rivoluzionari sulla sopravvivenza del suo farmaco immunoterapico pelareorep in diversi tipi di tumore. L'azienda ha riportato un significativo vantaggio di sopravvivenza a due anni del 21,9% contro il 9,2% negli studi sul cancro al pancreas (mPDAC). Nei trial sul carcinoma mammario metastatico HR+/HER2-, pelareorep ha mostrato un vantaggio mediano di sopravvivenza globale superiore a 10 mesi rispetto alla chemioterapia standard.
I principali risultati clinici includono un tasso di risposta obiettiva del 62% nel mPDAC quando combinato con chemioterapia e inibitori dei checkpoint. Il profilo di sicurezza del farmaco è stato confermato in oltre 1.100 pazienti, evidenziando effetti collaterali gestibili. Pelareorep ha ottenuto designazioni Fast Track sia per il carcinoma mammario metastatico che per il mPDAC, oltre a designazioni di farmaco orfano per il cancro al pancreas da parte di FDA ed EMA.
Oncolytics Biotech (NASDAQ: ONCY) ha anunciado datos transformadores sobre la supervivencia de su fármaco inmunoterapéutico pelareorep en varios tipos de tumores. La compañía reportó un beneficio significativo en la supervivencia a dos años del 21,9% frente al 9,2% en estudios de cáncer de páncreas (mPDAC). En ensayos de cáncer de mama metastásico HR+/HER2-, pelareorep demostró un beneficio en la supervivencia global mediana que supera los 10 meses en comparación con la quimioterapia estándar.
Los logros clínicos clave incluyen una tasa de respuesta objetiva del 62% en mPDAC cuando se combina con quimioterapia e inhibidores de puntos de control. El perfil de seguridad del fármaco ha sido validado en más de 1,100 pacientes, mostrando efectos secundarios manejables. Pelareorep cuenta con designaciones Fast Track tanto para el cáncer de mama metastásico como para mPDAC, junto con designaciones de medicamento huérfano para el cáncer de páncreas otorgadas por la FDA y la EMA.
Oncolytics Biotech (NASDAQ: ONCY)는 다양한 종양 유형에서 면역치료제 펠라레오렙의 획기적인 생존 데이터를 발표했습니다. 회사는 췌장암(mPDAC) 연구에서 2년 생존율이 21.9% 대 9.2%로 유의미한 개선을 보고했습니다. HR+/HER2- 전이성 유방암 임상 시험에서는 펠라레오렙이 표준 화학요법 대비 중앙 생존 기간이 10개월 이상 증가하는 효과를 보였습니다.
주요 임상 성과로는 화학요법 및 체크포인트 억제제와 병용 시 mPDAC에서 62%의 객관적 반응률을 기록한 점이 있습니다. 이 약물의 안전성 프로필은 1,100명 이상의 환자를 대상으로 검증되었으며, 관리 가능한 부작용을 나타냈습니다. 펠라레오렙은 전이성 유방암과 mPDAC 모두에 대해 패스트 트랙 지정을 받았으며, FDA와 EMA로부터 췌장암에 대한 희귀의약품 지정도 받았습니다.
Oncolytics Biotech (NASDAQ : ONCY) a annoncé des données transformantes sur la survie de son médicament immunothérapeutique pelareorep dans plusieurs types de tumeurs. La société a rapporté un bénéfice significatif de survie à deux ans de 21,9 % contre 9,2 % dans les études sur le cancer du pancréas (mPDAC). Dans les essais sur le cancer du sein métastatique HR+/HER2-, pelareorep a démontré un bénéfice médian de survie globale dépassant 10 mois par rapport à la chimiothérapie standard.
Les principales réussites cliniques incluent un taux de réponse objective de 62 % dans le mPDAC lorsqu'il est associé à la chimiothérapie et aux inhibiteurs de point de contrôle. Le profil de sécurité du médicament a été validé chez plus de 1 100 patients, montrant des effets secondaires maîtrisables. Pelareorep bénéficie de désignations Fast Track pour le cancer du sein métastatique et le mPDAC, ainsi que de désignations de médicament orphelin pour le cancer du pancréas délivrées par la FDA et l'EMA.
Oncolytics Biotech (NASDAQ: ONCY) hat bahnbrechende Überlebensdaten für sein Immuntherapie-Medikament Pelareorep bei verschiedenen Tumorarten bekannt gegeben. Das Unternehmen berichtete von einem signifikanten Zwei-Jahres-Überlebensvorteil von 21,9 % gegenüber 9,2 % bei Studien zum Bauchspeicheldrüsenkrebs (mPDAC). In Studien zum metastasierten HR+/HER2- Brustkrebs zeigte Pelareorep einen medianen Gesamtüberlebensvorteil von über 10 Monaten im Vergleich zur Standard-Chemotherapie.
Wichtige klinische Erfolge umfassen eine objektive Ansprechrate von 62 % bei mPDAC in Kombination mit Chemotherapie und Checkpoint-Inhibitoren. Das Sicherheitsprofil des Medikaments wurde bei mehr als 1.100 Patienten bestätigt und zeigt gut handhabbare Nebenwirkungen. Pelareorep besitzt Fast-Track-Designationen sowohl für metastasierten Brustkrebs als auch für mPDAC sowie Orphan-Drug-Designationen für Bauchspeicheldrüsenkrebs von FDA und EMA.
- None.
- Currently no approved immunotherapies for first-line mPDAC treatment, indicating regulatory hurdles ahead
- Some clinical trials had relatively small patient populations (13 patients in REO 029 study)
Insights
Pelareorep shows remarkable survival benefits in pancreatic and breast cancers, positioning for registration-enabling trials with FDA Fast Track status.
Oncolytics Biotech's pelareorep data represents a potential breakthrough in immunotherapy for traditionally unresponsive cancers. The 21.9% two-year survival rate in pancreatic cancer patients versus the 9.2% historical benchmark is particularly noteworthy, as pancreatic cancer has one of the poorest prognoses among solid tumors with minimal treatment advances in decades. This more than doubling of two-year survival stands out as clinically meaningful.
The 62% objective response rate in the combination study with checkpoint inhibitors is remarkably high for pancreatic cancer, where response rates to standard chemotherapy typically hover around 20-25%. This suggests pelareorep may effectively convert immunologically "cold" tumors into "hot" ones - addressing a fundamental challenge in pancreatic cancer treatment.
In HR+/HER2- metastatic breast cancer, the consistent survival benefit exceeding 10 months across two independent randomized studies provides compelling evidence of efficacy. The nearly doubled progression-free survival (12.1 vs 6.4 months) further supports pelareorep's potential.
The safety profile data from over 1,100 patients showing primarily manageable, transient flu-like symptoms is encouraging for an oncology therapeutic, particularly one administered intravenously. This favorable safety profile would facilitate combination approaches with existing standards of care.
The company's shift away from proof-of-concept studies toward registration-enabling trials, leveraging their Fast Track designations, suggests they've accumulated sufficient evidence to pursue a regulatory pathway. For an oncology immunotherapy platform showing efficacy in multiple difficult-to-treat cancers, this represents a significant inflection point in development.
Oncolytics pivots to registration trials after compelling survival data in multiple cancers, with Fast Track designation accelerating potential approval path.
Oncolytics' strategic pivot to registration-enabling studies represents a critical inflection point that fundamentally changes the company's risk profile. The company is transitioning from an early-stage biotech running proof-of-concept studies to one preparing for potential commercialization, which typically warrants a significant valuation reappraisal.
The dual FDA Fast Track designations (2017 for breast cancer, 2022 for pancreatic cancer) provide tangible regulatory advantages including more frequent FDA interactions, potential for accelerated approval, priority review, and rolling review of the Biologics License Application. These designations are granted only when data suggests a therapy may address serious conditions with unmet medical needs.
Pelareorep's demonstrated efficacy in two distinct, large market cancer indications substantially broadens its commercial potential. Pancreatic cancer represents a high-unmet need market with approximately 60,000 new cases annually in the US, while HR+/HER2- breast cancer accounts for about 70% of all breast cancers (over 200,000 new cases annually).
The company's statement that they are "no longer in the business of funding proof-of-concept studies" signals confidence in their existing data package and suggests a streamlined development path focused on registration trials. This approach conserves capital and accelerates time-to-market compared to conducting additional exploratory studies.
The robustness of data across multiple independent studies with consistent survival benefits reduces the scientific risk typically associated with single-study results. The demonstrated synergy with checkpoint inhibitors also suggests potential for combination approaches that could expand market opportunities beyond monotherapy.
Comparison with multiple landmark first-line metastatic pancreatic ductal adenocarcinoma studies substantiates strong two-year survival benefit of
Consistent survival benefit compared to standard-of-care chemotherapy in randomized studies in the large HR+/HER2- metastatic breast cancer indication
Data from over 1,100 patients across tumor types reveals a favorable, well-understood safety profile
"We are no longer in the business of funding proof-of-concept studies," said Jared Kelly, Chief Executive Officer of Oncolytics. "We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology."
Results from two completed first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) trials demonstrate a strong and consistent efficacy signal showing extremely rare 2-year overall survival rates of
Clinical results of pelareorep in first-line mPDAC studies | ||||
Company (Study) | Description | 1-Year Survival | 2-Year Survival | Notes |
Oncolytics | Pelareorep+ Gemcitabine (34 patients) | Disease Control Rate (DCR): Single arm vs. gemcitabine benchmark | ||
Oncolytics (NCI 8601) | Paclitaxel/Carboplatin + Pelareorep (36 patients) vs. Paclitaxel/Carboplatin (37 patients) | Randomized study vs. control arm (excluding crossover) | ||
Oncolytics (REO 029) | Pelareorep+ Gemcitabine/ Nab-Paclitaxel+ Atezolizumab (13 patients) | N/A | ORR: Single arm vs. gemcitabine/ nab-paclitaxel benchmark | |
Pelareorep's clinical activity in HR+/HER2- metastatic breast cancer – a large indication with continued significant unmet medical need and no currently approved immunotherapies – has been demonstrated in two randomized phase 2 studies, both of which showed a median overall survival (mOS) benefit of greater than 10 months compared to standard-of-care chemotherapy (IND.213 mOS: 21.0 vs. 10.8 months; BRACELET-1 mOS: not statistically reached; conservative estimate = 32.1 months vs. 18.2 months). In the randomized, controlled BRACELET-1 study, pelareorep combined with paclitaxel yielded a 12.1-month median progression-free survival (PFS) compared to 6.4 months in the paclitaxel alone control arm.
"Pelareorep represents a tipping point for immunotherapy in cold tumors," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "It is delivering consistent immunologic and clinical responses in multiple tumor types. Most impressively, pelareorep activates the immune system to produce clinical benefits in cancers that are typically unresponsive to immunotherapies like mPDAC and unresectable HR+/HER2- breast cancer, creating new oncology entry points for immune-based combination therapies."
Data from more than 1,100 patients enrolled in multiple studies across several tumor types affirm that pelareorep has a favorable, well-understood safety profile. The most common treatment-related adverse events (TRAEs) are "flu-like" symptoms, such as fever, chills, headache, fatigue, myalgia, cough, anorexia, nausea, diarrhea, or vomiting, and rarely resulted in clinically significant grade ≥3 TRAEs. Adverse events are typically transient and manageable with over-the-counter medications.
Pelareorep received Fast Track designations from the
The Company released a new corporate presentation, available on its website, that provides detailed clinical and translational data.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype – turning "cold" tumors "hot" – through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans, objectives and strategies; our focus on advancing pelareorep directly into registration-enabling trials; our plans to use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and
Company Contact
Jon Patton
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jpatton@oncolytics.ca
Investor Relations for Oncolytics
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